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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04267484
Other study ID # 118792
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 28, 2018
Est. completion date November 2021

Study information

Verified date February 2020
Source CHU de Quebec-Universite Laval
Contact France Légaré, PhD
Phone 418-663-5919
Email francelegare@mfa.ulaval.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Most older people want to stay at home as long as possible. Effective self-management for people losing autonomy depends on reliable monitoring of their mobility, health and safety and active implication in decision-making. New technologies have the potential to provide information about changing patterns that reflect changing care needs. This information could help older adults, caregivers and health professionals to participate in decision-making about housing options when a change in living environment needs to be considered.


Description:

This is a multi-phase study to be conducted in 3 countries: Canada (Quebec and Alberta), Sweden and Netherlands. The primary objective is to provide e-decision support technology that will facilitate self-management in the context of aging in place and foster informed value congruent decisions about options to age safely at home.

The aim of the project is to develop and validate a e-technology based on already existing components (e.g. GPS devices, diverse e-platforms and decision support interventions) to 1) help older adults with mild cognitive impairment/memory problems to stay safely at home as long as possible and 2) to provide older adults with decision support tools to help them make informed value congruent decisions (e.g. foster a shared decision-making process) regarding aging at home in a safe manner.

The secondary objectives are:

1. Assess autonomy and mobility of older adults with mild cognitive impairment/memory problems living at home.

2. Inform shared decision-making processes about options to safely age in place for all those involved.

The investigators will apply an integrated Knowledge Translation (iKT), comparative, mixed-methods approach to explore, older adults living at home with mild cognitive impairment/memory problems, their use of space in their homes and neighbourhoods.

The project is divide into 4 work package (WP). In more details, during WP1, the investigators will collect spatial data (e.g. using GPS) and self-reported data (e.g. travel diaries, walking interviews, in-depth interviews, surveys). At WP2, the investigators will use iterative end-user feedback and end-user consultation discussion group to tailor a decision support technology to knowledge-users. At WP3, investigators will assess user opinion regarding factors that could influence their use of the newly adapted e-decision support technology. Finally, at WP4 the investigators will triangulate data and take into account differences between jurisdictions.

This collaboration and our cross-country comparisons will contribute to scaling up e-decision support solutions in the future for the older adults with mild cognitive impairment/memory problems who want to age safely at home.


Recruitment information / eligibility

Status Recruiting
Enrollment 294
Est. completion date November 2021
Est. primary completion date August 2021
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Aged = 65 years

- Living at home

- Diagnosed with mild cognitive impairment or experiencing memory issues

- Able to read, understand and write

- Can provide informed consent

Exclusion Criteria:

- Older adults who are not able to provide informed consent

- Living in nursing home or hospital

Study Design


Intervention

Device:
GPS and travel diary
WP1: GPS tracker for 2 weeks and a daily diary about activity (travel diary).
Other:
e-decision support platform
WP2 and WP3: An e-decision support platform that will foster shared decision making about options to stay safe at home for the older adult.

Locations

Country Name City State
Canada University of Alberta Edmonton
Canada CERSSPL Québec Quebec
Netherlands University of Groningen Groningen
Sweden Dalarna University Falun

Sponsors (5)

Lead Sponsor Collaborator
CHU de Quebec-Universite Laval Dalarna University, Laval University, University of Alberta, University of Groningen

Countries where clinical trial is conducted

Canada,  Netherlands,  Sweden, 

References & Publications (5)

Caron CD, Ducharme F, Griffith J. Deciding on institutionalization for a relative with dementia: the most difficult decision for caregivers. Can J Aging. 2006 Summer;25(2):193-205. — View Citation

Garvelink MM, Emond J, Menear M, Brière N, Freitas A, Boland L, Perez MMB, Blair L, Stacey D, Légaré F. Development of a decision guide to support the elderly in decision making about location of care: an iterative, user-centered design. Res Involv Engage — View Citation

Greenhalgh T, Jackson C, Shaw S, Janamian T. Achieving Research Impact Through Co-creation in Community-Based Health Services: Literature Review and Case Study. Milbank Q. 2016 Jun;94(2):392-429. doi: 10.1111/1468-0009.12197. Review. — View Citation

Meijering L, Weitkamp G. Numbers and narratives: Developing a mixed-methods approach to understand mobility in later life. Soc Sci Med. 2016 Nov;168:200-206. doi: 10.1016/j.socscimed.2016.06.007. Epub 2016 Jun 8. — View Citation

Pot AM, Willemse BM, Horjus S. A pilot study on the use of tracking technology: feasibility, acceptability, and benefits for people in early stages of dementia and their informal caregivers. Aging Ment Health. 2012;16(1):127-34. doi: 10.1080/13607863.2011 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Autonomy and mobility assessment using GPS WP1: 1) Asses autonomy and mobility of older adults with mild cognitive impairment and memory problems living at home (including caregivers), their movement through their homes and neighborhoods (using GPS and walking interview); 2) how GPS data can support ongoing SDM about housing options for older adults. Participant will wear a GPS for a total of two weeks. As data collection will occur in parallel at all four sites (Quebec, Alberta, Sweden, Netherlands) data collection will happen over a period of 1 year
Primary Iterative assessment to tailor the e-decision support technology WP2: 1) Group discussion on if and how to incorporate GPS and adaptation of an existing e-platforms to create an adapted e-decision support technology (noted that the discussion focus will depend on result from WP1). Immediately after group discussion. 3 sequential group discussion are plan to occur, one in each country (Canada, Sweden, Netherlands) data collection will happen over a period of 1 year.
Primary User experience assessment of the newly adapted technology WP3: 1) Opinion of older adults with mild cognitive impairment, caregivers and health professionals about the adapted technology (noted that the final survey will depend on result from WP1 and WP2). Immediately after testing the new platform. As data collection will occur in parallel at all four sites (Quebec, Alberta, Sweden, Netherlands), it will happen over a period of 6 months
Secondary Inform SDM processes about housing option WP4: 1) Knowledge about differences and similarities between three countries 9 months
Secondary Open-ended questionnaire of participant global health status and their experience of using the GPS and filling the travel diary WP1: Participant will be ask to share their experience with the GPS and the travel diary Immediately before and after carrying the GPS at WP1. As data collection will occur in parallel at all four sites (Quebec, Alberta, Sweden, Netherlands) data collection will happen over a period of 1 year
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